Combining a Pharmacological Network Model with a Bayesian Signal Detection Algorithm to Improve the Detection of Adverse Drug Events

Introduction: Improving adverse drug event (ADE) detection is important for post-marketing drug safety surveillance. Existing statistical approaches can be further optimized owing to their high efficiency and low cost. Objective: The objective of this study was to evaluate the proposed approach for...

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Vydáno v:	Frontiers in pharmacology Ročník 12; s. 773135
Hlavní autoři:	Ji, Xiangmin, Cui, Guimei, Xu, Chengzhen, Hou, Jie, Zhang, Yunfei, Ren, Yan
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	Switzerland Frontiers Media S.A 03.01.2022
Témata:	adverse drug events FDA adverse event reporting system pharmacological network model Pharmacology pharmacovigilance signal detection algorithm adverse drug events FDA adverse event reporting system pharmacovigilance signal detection algorithm pharmacological network model
ISSN:	1663-9812, 1663-9812
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Shrnutí:	Introduction: Improving adverse drug event (ADE) detection is important for post-marketing drug safety surveillance. Existing statistical approaches can be further optimized owing to their high efficiency and low cost. Objective: The objective of this study was to evaluate the proposed approach for use in pharmacovigilance, the early detection of potential ADEs, and the improvement of drug safety. Methods: We developed a novel integrated approach, the Bayesian signal detection algorithm, based on the pharmacological network model (IC PNM ) using the FDA Adverse Event Reporting System (FAERS) data published from 2004 to 2009 and from 2014 to 2019Q2, PubChem, and DrugBank database. First, we used a pharmacological network model to generate the probabilities for drug-ADE associations, which comprised the proper prior information component (IC). We then defined the probability of the propensity score adjustment based on a logistic regression model to control for the confounding bias. Finally, we chose the Side Effect Resource (SIDER) and the Observational Medical Outcomes Partnership (OMOP) data to evaluate the detection performance and robustness of the IC PNM compared with the statistical approaches [disproportionality analysis (DPA)] by using the area under the receiver operator characteristics curve (AUC) and Youden’s index. Results: Of the statistical approaches implemented, the IC PNM showed the best performance (AUC, 0.8291; Youden’s index, 0.5836). Meanwhile, the AUCs of the IC, EBGM, ROR, and PRR were 0.7343, 0.7231, 0.6828, and 0.6721, respectively. Conclusion: The proposed IC PNM combined the strengths of the pharmacological network model and the Bayesian signal detection algorithm and performed better in detecting true drug-ADE associations. It also detected newer ADE signals than a DPA and may be complementary to the existing statistical approaches.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 This article was submitted to Drugs Outcomes Research and Policies, a section of the journal Frontiers in Pharmacology Edited by: Maribel Salas, Daiichi Sankyo United States Maurizio Sessa, University of Copenhagen, Denmark Reviewed by: Charles Khouri, Centre Hospitalier Universitaire de Grenoble, France
ISSN:	1663-9812 1663-9812
DOI:	10.3389/fphar.2021.773135